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DP Vs DFR for Management of Geriatric Distal Femur Fractures.

Primary Purpose

Distal Femur Fracture, Geriatrics

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
double plating
Distal femoral replacement
Sponsored by
Amr Gamaleldin Mahmoud Khalil Gendya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Femur Fracture focused on measuring Distal femoral fractures, Double plating, Distal femoral replacement, Geriatrics

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • AO 33 A3 and 33 C fractures
  • Age group ≥ 60 years
  • Closed fractures
  • Neurovascular intact

Exclusion Criteria:

  • Open fractures
  • Non ambulant patients
  • Patients with peripheral neurovascular diseases
  • Peri-prosthetic fractures
  • Associated other orthopedic injuries
  • Poly-traumatized patients
  • Pathological fractures

Sites / Locations

  • Ain Shams University - Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Fixation

Replacement

Arm Description

open reduction and internal fixation by using lateral and medial plates.

excision of the distal part of femur and replacement with distal femoral prosthesis

Outcomes

Primary Outcome Measures

change in Knee Society Score
the score has two-part, knee and function parts. The score is graded from 0 to 100 in each domain with 100 is the best outcome and 0 is the worst. The knee part assesses the range of motion, pain, and alignment of the joint while the function part assesses walking, stairs and usage of walking aids.

Secondary Outcome Measures

change in Knee range of motion
Assessment of range of motion of the knee which has normal range from 0 to 135
Postoperative complications
Assessment of postoperative complications either early or late complications
Reoperation rate
Recording the need for secondary operation for a cause related to the fracture union, postoperative complications, or prothesis problems.
Operative time
Recording of the operative time from the time of incision to the time of skin closure

Full Information

First Posted
April 27, 2022
Last Updated
July 18, 2023
Sponsor
Amr Gamaleldin Mahmoud Khalil Gendya
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1. Study Identification

Unique Protocol Identification Number
NCT05363943
Brief Title
DP Vs DFR for Management of Geriatric Distal Femur Fractures.
Official Title
Double Plating (DP) Fixation vs Distal Femoral Replacement (DFR) in the Management of Distal Femoral Fractures in Geriatric Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
August 20, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Amr Gamaleldin Mahmoud Khalil Gendya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study was to compare the functional and radiological outcomes of fixation by using double plating technique versus replacement using distal femur tumor prothesis as a primary management for the distal femoral fractures in geriatric patients. The hypothesis was that the distal femoral replacement will yield better functional outcome and earlier rehabilitation and return to pre-injury level of activity.
Detailed Description
Geriatric distal femoral fractures represent a major challenge for the orthopedic surgeons, to the present days still there is no definite algorithm or specific guidelines that can be used accurately in the management of these fractures. Unlike hip fractures however, there is no widely accepted treatment algorithm or standard of care. The surgical treatment of distal femoral fractures depends on both patient and fracture characteristics. Options include conservative treatment, open reduction internal fixation, intramedullary nails, or recently distal femoral replacement. There is currently a move towards distal femoral replacement (DFR) for these complex fractures which has the potential benefit of allowing early weight bearing, and therefore aiming to prevent complications associated with immobility and non-union. Using distal femoral replacement had yield good results in small case series, as it allows immediate full weightbearing, eliminate the risk of nonunion and may provide greater satisfaction scores. However, DFR has its own risks, most notably deep infection, and loosening. While a DFR is more costly compared with fixation plates and nails, the initial increased cost may be outweighed by faster rehabilitation and return to the patient's usual place of residence. In the study, the investigators are aiming to compare the functional and radiological outcomes of fixation by using double plating technique versus replacement as a primary management for the geriatric distal femoral fractures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Femur Fracture, Geriatrics
Keywords
Distal femoral fractures, Double plating, Distal femoral replacement, Geriatrics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fixation
Arm Type
Active Comparator
Arm Description
open reduction and internal fixation by using lateral and medial plates.
Arm Title
Replacement
Arm Type
Experimental
Arm Description
excision of the distal part of femur and replacement with distal femoral prosthesis
Intervention Type
Procedure
Intervention Name(s)
double plating
Intervention Description
open reduction and internal fixation by using lateral and medial plates.
Intervention Type
Procedure
Intervention Name(s)
Distal femoral replacement
Intervention Description
excision of the distal part of femur and replacement with distal femoral prosthesis
Primary Outcome Measure Information:
Title
change in Knee Society Score
Description
the score has two-part, knee and function parts. The score is graded from 0 to 100 in each domain with 100 is the best outcome and 0 is the worst. The knee part assesses the range of motion, pain, and alignment of the joint while the function part assesses walking, stairs and usage of walking aids.
Time Frame
1 month, 6 month and 12 month
Secondary Outcome Measure Information:
Title
change in Knee range of motion
Description
Assessment of range of motion of the knee which has normal range from 0 to 135
Time Frame
1 month and 12 month
Title
Postoperative complications
Description
Assessment of postoperative complications either early or late complications
Time Frame
form first day to 12 month
Title
Reoperation rate
Description
Recording the need for secondary operation for a cause related to the fracture union, postoperative complications, or prothesis problems.
Time Frame
form first day to 12 month
Title
Operative time
Description
Recording of the operative time from the time of incision to the time of skin closure
Time Frame
At the operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: AO 33 A3 and 33 C fractures Age group ≥ 60 years Closed fractures Neurovascular intact Exclusion Criteria: Open fractures Non ambulant patients Patients with peripheral neurovascular diseases Peri-prosthetic fractures Associated other orthopedic injuries Poly-traumatized patients Pathological fractures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amr GM Gendya, MSc Ortho.
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams University - Faculty of Medicine
City
Cairo
ZIP/Postal Code
1181
Country
Egypt

12. IPD Sharing Statement

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DP Vs DFR for Management of Geriatric Distal Femur Fractures.

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